Daily Rules, Proposed Rules, and Notices of the Federal Government
On February 4, 2011, Administrative Law Judge Timothy D. Wing issued the attached recommended decision. Neither party filed exceptions to the decision.
Having reviewed the entire record, I have decided to adopt the ALJ's ruling, findings of fact, conclusions of law (except as explained below), and recommended order. Accordingly, Respondent's application for a registration will be granted subject to a condition.
In his discussion of factor three--Respondent's "conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances," 21 U.S.C. 823(f)--the ALJ found that she had pled guilty to a felony count of obtaining a narcotic drug by means of a forged prescription in violation of Cal. Health & Safety Code SS 11368. ALJ at 15-16.
Noting that California law provides that "[a] defendant's plea of guilty pursuant to this chapter shall not constitute a conviction for any purpose unless a judgment of guilty is entered pursuant to" Cal Penal Code SS 1000.3, and that Agency precedent holds that a deferred adjudication is nonetheless a conviction for purposes of the CSA, the ALJ explained that "the fact that a finding of guilt was specifically not entered as to Respondent and the charges dismissed, leaves open the question as to whether Respondent's plea constitutes a conviction under 21 U.S.C. 823(f)." ALJ at 17. The ALJ deemed it unnecessary to reach the issue, however, reasoning that the offense committed by Respondent "does not 'relate to the manufacture, distribution, or dispensing of controlled substances,' the standard embraced in" 21 U.S.C. 823(f)(3).
Contrary to the ALJ's understanding, the Agency has long since resolved both issues. In
Thereafter, the Agency proposed the revocation of the practitioner's registration on the ground that he had been convicted of a felony offense relating to controlled substances under state or Federal law.
The Agency rejected the practitioner's argument, explaining that "there is still a 'conviction' within the meaning of the Controlled Substances Act even if the proceedings are later dismissed. * * * [A]ny other interpretation would mean that the conviction could only be considered between its date and the date of its subsequent dismissal."
More recently, in
Moreover, the Superior Court form evidencing Respondent's guilty plea includes the "Court's Finding And Order." GX 9, at 3. This section of the form concludes by stating: "The Court accepts the defendant's plea and admissions, and the defendant is convicted thereby."
As discussed above, the ALJ also concluded that Respondent's offense of obtaining a prescription for a controlled
Most significantly, in several cases, the Agency has held that the offense of obtaining controlled substances by using fraudulent prescriptions constitutes an offense related to the manufacture, distribution, or dispensing of controlled substances within the meaning of factor three.
However, aside from the ALJ's analysis of factor three, I agree with the ALJ's findings as to the remaining factors. Moreover, I agree with the ALJ that Respondent has "credibly" accepted responsibility for her misconduct and that she has put forward compelling and unrebutted evidence of her rehabilitation, thus demonstrating that "she will not engage in future misconduct." ALJ at 22. Because there is no evidence that Respondent harmed others or diverted the drugs she illegally obtained, and this episode is, in essence, a first offense, I conclude that consideration of the Agency's interest in deterrence is not warranted. Accordingly I will adopt the ALJ's recommended order and grant Respondent's application for registration subject to the following condition.
(1) Any violation of either condition 13 or 14 of the California Board of Registered Nursing's Order shall be deemed an act inconsistent with the public interest and subject her registration to proceedings under 21 U.S.C. 824(a).
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Kimberly Maloney, N.P., for a DEA Certificate of Registration as a mid-level practitioner be, and it hereby is, granted. This Order is effective immediately.
Timothy D. Wing, Administrative Law Judge. This proceeding is an adjudication pursuant to the Administrative Procedure Act (APA), 5 U.S.C. 551
On September 10, 2010, the DEA Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause
In substance, the OSC alleges that:
Whether the record establishes by substantial evidence that Respondent's application for a DEA COR, Control Number W09131151M, as a mid-level practitioner, should be denied pursuant to 21 U.S.C. 823(f) and 824(a)(4), because Respondent's registration would be inconsistent with the public interest as that term is used in 21 U.S.C. 823(f).
The parties stipulated as fact the allegations contained within the OSC. (Tr. 17.) Additionally, at hearing the parties stipulated to the admission and consideration of Government Exhibits 1-16 and Respondent Exhibits 1-8. (Tr. 16.)
Respondent's education includes: A 1992 Bachelor of Science degree in Biology from San Diego State University, a 1995 Bachelor of Science degree in nursing from San Diego State University and a 2000 Masters of Science/Nurse Practitioner Critical Care degree from the University of Pennsylvania. (Resp't Ex. 2.) Additionally, Respondent's professional experience between August 2000 and November 2006 includes work as a nurse practitioner in various medical settings to include neurosurgical patient care, neuro-radiology and a trauma department. (
At hearing, the Government presented the testimony of two witnesses: DEA Diversion Investigator Lucia Bartolomeo (DI Bartolomeo) and DEA Diversion Investigator Ayoma Rudy (DI Rudy). DI Bartolomeo credibly testified in substance that she has been a diversion investigator with DEA for approximately twenty-two years and has been assigned during that time to the DEA San Diego Field Division. (Tr. 21.) DI Bartolomeo's education and training includes basic diversion investigator training along with a Bachelor of Science degree. (Tr. 21.) DI Bartolomeo began an investigation of Respondent in 2006 after receiving an investigative lead that Respondent was in possession of a prescription pad, not her own, and possibly forging controlled substance prescriptions to obtain oxycodone and fentanyl for herself. (Tr. 22.)
The evidence further included two California Controlled Substance Utilization Review and Evaluation System (CURES) patient activity reports for Respondent, obtained by DI Bartolomeo as part of her investigation of Respondent. (Gov't Ex. 3; Tr. 22.) The first CURES report covers the time period from September 2003 to October 2006 and the second from December 2006 to April 2007. (Gov't Ex. 3.) The first report reflects numerous prescriptions for oxycodone and Actiq, the brand name for fentanyl; in the majority of instances the pharmacy listed is Bonita Pharmacy. (
DI Bartolomeo testified that she met with Respondent on December 18, 2006, and Respondent admitted to forging prescriptions and identified nine prescriptions that she forged. (Tr. 27;
Documentary evidence submitted by the Government also included a July 31, 2009 Accusation filed by the California BRN, alleging four causes of discipline against Respondent for unprofessional conduct, specifically: "Possession of Controlled Substances Without a Prescription"; "Use of a Controlled Substance"; "Prescription Forgery"; and Violation of the Nursing Practice Act." (Gov't Ex. 13.) The Accusation states in relevant part that
On April 1, 2007, Respondent voluntarily surrendered her DEA COR "while in treatment for substance abuse." (Gov't Ex. 1 at 3.)
DI Rudy credibly testified in substance that she has been assigned to the DEA San Diego Field Division as a diversion investigator since 2005, and her education includes a Bachelor's degree in criminal justice. (Tr. 35.) DI Rudy testified that she became involved in the investigation of Respondent in February 2009 when Respondent applied for a DEA registration as a mid-level practitioner. (Tr. 36.) DI Rudy further testified that at the time of application, Respondent was exempt from payment of an application fee because Respondent's proposed registered location at that time was a state university. (Tr. 37-38, 41;
The Government's documentary evidence included a handwritten confession by Respondent dated December 18, 2006, describing several life stresses and admitting to taking "the prescription pads because I was scared that my migraines were out of control, that I would need more medicine.
The record also contains a February 8, 2007 letter from the McDonald Center for Alcoholism and Drug Addiction Treatment, La Jolla, California (McDonald Center), certifying that Respondent successfully completed an intensive, seven-week outpatient alcohol and drug rehabilitation program on February 8, 2007, noting that Respondent "showed a high level of commitment to her sobriety * * * was a willing participant in all aspects of the program [and] completed all of her written assignments on time." (Gov't Ex. 6.)
Finally, the record reveals that on January 19, 2007, the San Diego District Attorney's Office filed a felony complaint against Respondent for violations of Cal. Health & Safety Code SS 11173(a) (obtaining prescriptions by fraud or deceit) and Cal. Penal Code SS 459 (burglary). (Gov't Ex. 8.) On April 17, 2007, Respondent pleaded guilty to a felony count of obtaining a narcotic drug (OxyContin) by means of a forged prescription, in violation of California Health & Safety Code SS 11368. (Gov't Ex. 9.) The court deferred entry of judgment for eighteen months and ordered Respondent to enroll in and complete a California Penal Code SS 1000 drug treatment program. (Gov't Ex. 10.) On October 22, 2008, the court dismissed the felony criminal complaint against Respondent. (Gov't Exs. 11 & 12.)
Respondent testified at hearing and also presented testimony from her father, Mr. William Mayer. Respondent credibly testified in substance that she became a registered nurse in 1995 and candidly admitted to the fact that she became addicted to prescription medications and was "guilty of egregious behavior when I made unprofessional choices that led to my chemical dependence." (Tr. 44.)
Respondent explained that in or about 1990 she began having migraine headaches "and saw many health practitioners for this problem, and tried every therapy that was recommended." (Tr. 45.) In 2000 her neurologist began prescribing different narcotic medications such as OxyContin, Vicodin, Actiq and Dilaudid for maintenance and rescue therapy. (Tr. 45.) Respondent stated the medications helped initially but did not resolve the migraine headaches, and she was prescribed more of the same narcotic or larger doses over time. (Tr. 45-46.) Respondent also testified that she experienced a series of very difficult life events which increased her stress,
Respondent next testified that she attempted to discuss her concern that she was becoming addicted to narcotics with her treating physician, but the physician did not believe that intervention was warranted. (Tr. 46.) Responded admitted that she "eventually betrayed his trust" by forging his name to acquire more narcotics, but that not "long after, I called a therapist I had recently been seeing, and told him what I had done, and asked for help." (Tr. 46.)
Respondent testified that she started an outpatient drug treatment program on December 21, 2006, and completed the program on February 8, 2007. (Tr. 46.) Thereafter, Respondent completed a year-long aftercare program running between February 8, 2007 and February 2008. (Tr. 46.) From April 2007 to February 2009, Respondent participated in the BRN Nursing Diversion Program, but was dismissed on the grounds that she "admitted a patient to the hospital ward, and the computer admission orders included orders for [o]xycodone." (Tr. 46-47.) Respondent was told that this was equivalent to dispensing oxycodone. (Tr. 47.) In mitigation, Respondent testified that "I have not dispensed medications in over ten years, and the orders were part of a standardized set for all cancer patients." (Tr. 47.)
With regard to the circumstances of Respondent's dismissal from the BRN Nursing Diversion Program, the evidence also included the following factual information:
Respondent's father, Mr. Mayer, credibly testified in part and in substance that he is a retired Certified Public Accountant, and lives approximately three miles from Respondent, seeing her at least weekly. (Tr. 81.) Mr. Mayer testified to what he described as a "double whammy" inflicted on Respondent by her treating physician and two drug companies, explaining that Respondent's treating physician "prescribed OxyContin and Actiq for [Respondent's] migraine headaches, although her stresses were far beyond migraine headaches at that time." (Tr. 70.) Mr. Mayer further explained that prescribing "OxyContin, which was marketed as less addictive and less subject to abuse, when it was not, and Actiq, which the FDA had only approved for cancer patients" in combination to treat Respondent's migraine headaches, significantly contributed to Respondent becoming
Respondent's documentary evidence included,
Respondent also submitted a September 6, 2008 Certificate of Attendance reflecting successful completion of eight hours of continuing education in Pharmacology In Addiction and eight hours in Relapse Prevention. (Resp't Ex. 3.) Respondent also submitted letters dated September and August 2009 from two friends and colleagues, Linda Long, R.N., M.S.N., F.N.P., and Linnea Trageser, N.P., both attesting to Respondent's professionalism and qualifications to practice. (Respt' Ex. 4 at 1-4.) A September 2009 letter from Respondent's parents thoughtfully describes Respondent's addiction to prescription medications, including the causes, as well as her successful efforts at rehabilitation and continued abstinence. (Resp't Ex. 4 at 5.) A March 11, 2010 letter of personal reference from Alison McManus, Family Nurse Practitioner, a friend of Respondent and her co-worker from April to November 2009, describes Respondent as "always professional" and "punctual and reliable, organized, efficient, and competent." (Resp't Ex. 5 at 1.) Three other letters dating from February 2008 to February 2009, written by a former student, supervisor and co-worker, respectively, refer to Respondent as a dedicated professional and "inspirational role model." (
The record reflects that on September 10, 2007, Respondent was recertified as an Acute Care Nurse Practitioner, effective September 1, 2007, to August 31, 2012. (Resp't Ex. 6.)
Letters dated March 25, 2008, and September 9, 2009, from Steven F. Bucky, PhD, Clinical Psychologist, report in relevant part that Respondent has been seen in psychotherapy for approximately two years and "is progressing well with no evidence of drug, alcohol, or prescription drug use." (Resp't Ex. 7 at 1-2.)
A July 5, 2007 letter by Dr. Marina Katz, M.D., documents a June 18, 2007 psychiatric evaluation of Respondent. The report assesses Respondent's opiate dependence and finds that it is in remission, noting that Respondent is active in Narcotics Anonymous (NA), and cautiously gives Respondent a favorable prognosis. (Resp't Ex. 7 at 5-6.)
A September 4, 2008 letter from Kristine M. Vickery, R.N., Facilitator of the San Diego Nurse to Nurse peer support group, notes Respondent's weekly attendance at the support group since April 2007, describing Respondent as a "determined, motivated individual who is genuinely committed to recovery from chemical dependency." (Resp't Ex. 8 at 1.) The letter further notes Respondent's "sobriety date is November 29, 2006 and she maintained negative drug/ETG tests since her entrance into the [Nursing] Diversion Program. Additionally, a hair follicle test was performed in June 2007, and it was negative, as well." (
The Controlled Substances Act (CSA) provides that any person who dispenses (including prescribing) a controlled substance must obtain a registration issued by the DEA in accordance with applicable rules and regulations.
It is unlawful for any person to possess a controlled substance unless that substance was obtained pursuant to a valid prescription from a practitioner acting in the course of professional practice.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an application for a DEA COR if she determines that such registration would be inconsistent with the public interest. In determining the public interest, the Deputy Administrator is required to consider the following factors:
(1) The recommendation of the appropriate state licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws relating to the manufacture, distribution or dispensing of controlled substances.
(4) Compliance with applicable state, Federal or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
As a threshold matter, the factors specified in Section 823(f) are to be considered in the disjunctive: The Deputy Administrator may properly rely on any one or a combination of those factors, and give each factor the weight she deems appropriate, in determining whether a registration should be revoked or an application for registration denied.
In addition to the public interest factors discussed above, 21 U.S.C. 824(a) provides four other factors that the Deputy Administrator may consider in a proceeding to suspend or revoke a DEA COR.
As described in the Evidence and Incorporated Findings of Fact Section of this Recommended Decision, Respondent holds active state authority
The evidence at hearing reflects that the BRN complaint against Respondent was the subject of a March 29, 2010 California administrative hearing, during which the BRN recommended that Respondent be placed on a three-year period of probation, with specified terms and conditions. (
In mitigation, the Proposed Decision ordered revocation of Respondent's state nursing licenses, but stayed the revocation and placed Respondent on probation for two years, with specified terms and conditions. (Resp't Ex. 1 at 6-7.) Of note, the state ALJ found substantial evidence of Respondent's rehabilitation and sobriety, concluding that two rather than three years of probation would be "adequate for the board to monitor respondent to ensure public protection." (Resp't Ex. 1 at 6.) On December 28, 2010, the BRN issued a Decision After Non-Adoption, which was consistent with the Proposed Decision, except it further reduced the period of probation to one year and reduced Respondent's costs to zero. (Gov't Br. at Gov't Ex. 17.)
The most recent action by the California BRN reflects a determination that notwithstanding findings of unprofessional conduct, Respondent can be entrusted with an active license subject to probationary terms and conditions. While not dispositive,
As noted above, one of the factors in determining whether Respondent's registration would be inconsistent with the public interest is "[t]he applicant's conviction record under Federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances." 21 U.S.C. 823(f)(3).
Federal case law has established that "[a] conviction
The policy underlying this precedent is founded in the doctrine of claim preclusion. "When the judge decided to withhold adjudication and sentence and instead placed the defendant on probation * * * it is clear that the defendant could no longer be tried on the information."
In this case, the fact that a finding of guilt was specifically not entered as to Respondent and the charges dismissed, leaves open the question as to whether the foregoing Agency precedent is controlling on the issue of whether Respondent's plea constitutes a conviction under 21 U.S.C. 823(f).
Accordingly, I find that Respondent has not been convicted of any laws relating to the manufacture, distribution or dispensing of controlled substances. I therefore find that Factor Three under Section 823(f), while not dispositive, does weigh in favor of a finding that Respondent's registration would be consistent with the public interest.
The central issue in this case centers on Respondent's addiction to prescription pain medications, which began in or about 2006 while under medical care for chronic migraine headaches. (
As to the single instance of Respondent's noncompliance with controlled substance laws following her sobriety date, there is evidence of record that Respondent was dismissed in February 2009 from a Nursing Diversion Program, during her employment as a nurse practitioner in a bone marrow transplant unit, on the grounds that a computer-generated admission order for a patient automatically included an order for oxycodone. (
As an initial matter, the issue of Respondent's dismissal from the Nursing Diversion Program due to improper dispensing of oxycodone was not specifically noticed by the Government in the OSC or prehearing statement, nor was it referenced in any Government exhibits prior to hearing. The issue was introduced by Respondent at hearing during her direct testimony as well as in documentary evidence. (Tr. 47; Resp't Ex. 1 at 4.)
To comport with due process requirements, the DEA must "provide a Respondent with notice of those acts which the Agency intends to rely on in seeking the revocation of [her] registration so as to provide a full and fair opportunity to challenge the factual and legal basis for the Agency's action."
In accordance with agency precedent, I find in this case that the issue of Respondent's February 2009 dispensing of oxycodone may properly be considered in evaluating Respondent's application, as well as on the issue of sanction. I also find that Respondent's conduct culminating in the single instance of dispensing oxycodone in February 2009 was inadvertent. The record reveals that
(Resp't Ex. 1 at 4.) The circumstances of this single incident and Respondent's early termination from the Nursing Diversion Program after approximately twenty-two fully successful months does not weigh against Respondent's application for DEA registration. I also note that as with all other aspects of Respondent's testimony, Respondent was fully credible and candid in her explanation of this incident.
The Government maintains that Factors Four and Five are relevant to the public interest inquiry, relying in part on the undisputed evidence of Respondent's history of self-abuse of controlled substances, and citing
Other cases reflect long-held "precedent that a practitioner's self-abuse of controlled substances constitutes `conduct which may threaten public health and safety.'"
In the instant case, the evidence is undisputed that Respondent's conduct between approximately June and December 2006 violated federal and state law and reflected a serious drug addiction by Respondent during that time period of approximately six months.
Additionally, the evidence regarding Respondent's acknowledgement of her addiction includes a December 18, 2006 interview at the San Diego Bureau of Narcotics Enforcement office, where Respondent initially denied forging any prescriptions, but eventually admitted that she had stolen the prescription pad and forged prescriptions for OxyContin and Actiq.
To summarize, Respondent's admitted misconduct and substance abuse between June and December 2006, if viewed standing alone, does weigh against a finding that Respondent's unconditional registration would be consistent with the public interest under Factors Four and Five.
After balancing the foregoing public interest factors, I find the Government has established by substantial evidence a
Additionally, where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for his or her actions and demonstrate that he or she will not engage in future misconduct.
In the instant case, Respondent's testimony at hearing with regard to her past misconduct, and demonstrated efforts to avoid a repeat of those mistakes, was fully credible. Respondent's testimony was consistent and candid throughout her direct and cross examination. With regard to the facts surrounding her misconduct, Respondent credibly assumed full responsibility for her actions, stating at the outset of her testimony that "I was guilty of egregious behavior when I made unprofessional choices that led to my chemical dependence." (Tr. 44.) The Government argues that Respondent "appeared to accept responsibility," but that "her father attempted to shift the blame for Respondent's addiction to her physician and two drug manufacturers." (Gov't Br. at 5.) The relevant inquiry, however, is Respondent's own acceptance of responsibility, not that of a third party.
The evidence and testimony demonstrating Respondent's efforts to ensure that she will not engage in future misconduct relating to drug addiction is substantial and compelling. The Government "contends that Respondent needs additional time to demonstrate she can remain free from drug abuse and to solidify her recovery."
Respondent's abstinence from drug abuse since 2006, and her efforts at rehabilitation have been consistent, substantial, and successful. The uncontroverted evidence of rehabilitation shows that Respondent: successfully completed a seven-week outpatient alcohol and drug treatment program (Gov't Ex. 6); successfully completed a one-year dependency aftercare program (Gov't Ex. 7); successfully participated in a Nursing Diversion Program for twenty-two months (Resp't Ex. 1 at 4); regularly attended AA and NA meetings (Resp't Ex. 7 at 5-6; Resp't Ex. 8 at 2); regularly attended nurse-to-nurse meetings (Resp't Ex. 1 at 4); and has had sustained sobriety since December 2006, as evidenced by repeated negative random drug tests (
Accordingly, I recommend that Respondent's application for DEA COR be granted, subject to the following conditions: (1) Respondent shall comply with all of the terms and conditions specified in the December 28, 2010 Order of the California BRN (